The FDA and EMA’s unwavering request:
submitting phase-appropriate genetic data over the course
of your ATMP development
Recorded Thursday 6 April 2023
The cell & gene therapy (CGT) field continues to progress at an exponential pace. Yet, the road to developing these game-changing therapies and their path to commercialization have been met with non-trivial bumps along the way. In fact, several companies saw their clinical trials come to a halt over the last years due to the detection of chromosomal abnormalities. These hard reality checks clearly underscore the importance of comprehensive genetic characterization and QC during ATMP manufacturing. Shortly after, reactive guidelines from the FDA were drafted and publicly released. While many aspects are covered in more detail within these documentations, it is undisputable that regulators want sponsors to gather sufficient information over the course of product development and encourage submitting data in a stage-appropriate manner. Among others, great emphasis is placed on fully characterizing genetic engineering outcomes.
In this webinar, we covered:
- How companies that overlook or underestimate genetic QC often pay a heavy price, with regulators placing a clinical hold on their program(s)
- What regulatory authorities want to see when it comes to genetic data for successful ATMP filings
- How our TLA-based approach yields critical genetic quality attributes in a single experiment and results in an actionable report
- How our risk mitigation services can enhance your odds of securing a favorable filing outcome